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Association details:
| Biomarker: | TP53 mutation |
|---|---|
| Cancer: | Chronic Lymphocytic Leukemia |
| Drug: | Zydelig (idelalisib) (PI3Kδ inhibitor) + Arzerra (ofatumumab) (CD20 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
09/18/2014
Excerpt:
Zydelig is indicated in combination with an anti‑CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):...as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies...
Source:
Title:
Efficacy and safety of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukaemia: an open-label, randomised phase 3 trial
Excerpt:
Patients were stratified by relapsed versus refractory disease, presence or absence of del(17p) or TP53 mutation, or both...median progression-free survival was 16·3 months (95% CI 13·6–17·8) in the idelalisib plus ofatumumab group and 8·0 months (5·7–8·2) in the ofatumumab group (adjusted hazard ratio [HR] 0·27, 95% CI 0·19–0·39, p<0·0001)....The idelalisib plus ofatumumab combination resulted in better progression-free survival compared with ofatumumab alone in patients with relapsed CLL...
DOI:
10.1016/S2352-3026(17)30019-4
Trial ID:
